CORE BIOSTATISTICS will reside within the University of Pittsburgh Cancer Institute's (UPCI) Biostatistics Facility, which provides clinical and basic-science investigators in UPCI with statistical and computer-related expertise in design, execution, analysis, and reporting of cancer-related research studies. These cover basic-science studies; phase I and phase II oncology clinical trials; epidemiologic studies, including those related to cancer prevention and awareness; and investigations of behavioral and health sequellae of cancer treatment. In its role as Core for this Program Project, the Biostatistics Core will support all three Projects with respect to statistical aspects of study design and data analysis, and contribute as well to statistical aspects of quality control and assay quantitation in the IMCPL / Flow Cytometry Core. Specifically, the Biostatistics Core will collaborate with the Program-Project investigators on statistical aspects of the design of the laboratory-based studies as new data come to light, and perform both exploratory and confirmatory statistical analyses of the resulting data from key experiments; collaborate on developing final versions of protocols for the clinical trials that are planned; perform interim analyses of safety for the Program Project's clinical trials, and final analyses of safety, immune response, and efficacy; work with investigators to ensure that data collection and reporting of the laboratory-based data and clinical trial data are appropriate for the requisite statistical analyses; establish databases that link laboratory-based data and clinical-trial data where needed; provide consultation to investigators on issues of quality control and assay quantitation for laboratory-based studies; and collaborate with investigators in writing and preparing progress reports, abstracts, manuscripts, and presentations.